Baxter, Novavax Ink Sterile Manufacturing Agreement

Baxter BioPharma Solutions has entered into an agreement to provide sterile manufacturing services for NVX-CoV2373, Novavax’ COVID-19 recombinant nanoparticle vaccine candidate with Matrix-M adjuvant. Baxter BioPharma Solutions is a contract manufacturing organization (CMO) that specializes in parenteral (injectable) pharmaceuticals, including vaccines. The agreement is expected to advance commercial-scale manufacturing essential for the vaccine’s production and distribution in the UK and European markets. Novavax’ COVID-19 vaccine candidate is currently in phase 3 trials and has not yet been authorized or approved for use.

“The quest to develop vaccines for COVID-19 has reinforced the opportunity for industry partners to work together and contribute their unique capabilities and expertise for the benefit of all,” said Marie Keeley, vice president, Baxter BioPharma Solutions. “We welcome the opportunity to work with an innovative company like Novavax and look forward to helping bring their vaccine candidate to the market.”

According to Novavax, NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 disease nor can it replicate, is stable at 2°C to 8°C and is manufactured in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.

“Our priority is to bring a safe, effective COVID-19 vaccine to people around the world,” said Rick Crowley, executive vice president, chief operations officer, Novavax. “Partners like Baxter
BioPharma Solutions are enabling Novavax to quickly establish a commercial supply chain network to ensure access for global populations, and ultimately help bring about an end to the global COVID-19 pandemic.”

Baxter’s manufacturing services for NVX-CoV2373 will take place at its state-of-the-art facility in Halle/Westfalen, Germany. The site has broad sterile manufacturing capabilities and areas of focus, offers current good manufacturing practices (cGMP) manufacturing with dedicated production areas and is designed to deliver products with optimum efficiency and speed to market. Baxter’s recently expanded Halle/Westfalen facility has been in operation for more than 60 years.